Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel™ (Ketoprofen Topical Cream 10%) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.

Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.

Study Overview

• Status: Completed
• Conditions: Sprain; Strain; Acute Soft Tissue Injury
• Intervention / Treatment: Drug: Topical Ketoprofen 10% Cream; Drug: Topical Placebo Cream

Detailed Description

The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day period.

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • CATO Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 70 years of age
• Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit.
• The injury site must be accessible to the patient so that he or she can apply the study treatment himself or herself.
• Meet pain entry criteria.
• Willing to discontinue use of any pain medication or treatments not provided as part of the study.

Exclusion Criteria:

• Grade 3 sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or have a serious injury, as determined by the investigator (e.g., nerve damage, joint instability, or tendon rupture).
• Previous injury to the same area within 3 months prior to current injury.
• Active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules, vesicles, and erythema associated with the site of injury.
• Pharmacologic treatment (NSAIDs or analgesic medications) for the injury less than 12 hours before the baseline assessments.
• Any form of opioid use since the time of injury.
• Any form of steroid use within 30 days prior to study entry.
• Non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) prior to the baseline visit.
• History or physical examination finding that is not compatible with safe participation in the study as determined by the study doctor, such as gastrointestinal (stomach, intestine) ulcer or bleeding within 6 months documented by an upper-gastrointestinal series (UGI x-ray, barium meal) or endoscopy (GI scope), anemia or abnormal bleeding, moderate to severe kidney disease, or moderate to severe liver disease.
• A history of, or evidence for, underlying disease in the injured area, such as osteoarthritis or gout.
• Clinically significant, poorly controlled lung, stomach, liver, kidney, heart, or other vital organ disease as determined by the study doctor or nurse.
• A history of allergy to ketoprofen or ketoprofen-containing products.
• A history of allergy to soy lecithin or soy lecithin-containing products.

• Medications (drugs) or other substances contraindicated due to the nature of study medication that include:

  • Allergies to prescription or over-the-counter products containing acetaminophen (e.g., Tylenol®), which is used as rescue medication
  • History of aspirin-sensitive asthma, or aspirin-associated rhinitis or nasal polyps
  • Taking warfarin, parenteral heparin, ticlopidine or clopidogrel
  • Taking lithium or methotrexate
  • Taking probenecid or similar drugs that might affect the kidneys
• Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication.
• Scheduled elective surgery or other invasive procedures during the period of study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketoprofen 10% Cream; Topical Ketoprofen 10% Cream 1gram three times daily for 7 days	Drug: Topical Ketoprofen 10% Cream; Topical Administration; Other Names: Ketotransdel (TDLP-110)
Placebo Comparator: Placebo; Topical placebo cream 1gram three times daily for 7 days	Drug: Topical Placebo Cream; Topical Administration; Other Names: Placebo; Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the safety, tolerability and other parameters of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury of upper and lower extremities.	14 days

Other Outcome Measures

Outcome Measure	Time Frame
To assess the pharmacokinetics of ketoprofen after 7 days of topical application	8 days

Collaborators and Investigators

• Sponsor: Imprimis Pharmaceuticals, Inc.
• Collaborators: Cato Research
• Investigators: Study Director: Illana Katsnelson, MD, CATO Research

Publications and helpful links

General Publications

• E. Ekman, S. Skrepnik, M. Jones , K. Lawson, and J. Schupp. EFFICACY AND SAFETY OF KETOPROFEN 10% CREAM IN ACUTE SOFT TISSUE INJURIES (PHASE 3 STUDY TDLP-110-001). Poster Presentation, Sep. 2, 2010, 13th World Congress on Pain in Montreal, Canada.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: September 20, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Shoulder Pain; Knee pain; Sprain; Strain; Ankle Pain; Muscle, Bone and Cartilage Disorders; Tennis Elbow; Elbow Pain; Wrist Pain; Hand Pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Soft Tissue Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: TDLP-110-101